Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00306787
First received: March 22, 2006
Last updated: June 28, 2011
Last verified: June 2011

March 22, 2006
June 28, 2011
March 2006
February 2008   (final data collection date for primary outcome measure)
Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.
Not Provided
Complete list of historical versions of study NCT00306787 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Aborted Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
    Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.
  • Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
    Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.
  • Time to Resolution of Symptoms Associated With Recurrent Genital Herpes [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
    Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.
  • Number of Patients With a Second Recurrence of Genital Herpes [ Time Frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes ] [ Designated as safety issue: No ]
    Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.
  • Time to a Second Recurrence of Genital Herpes [ Time Frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes ] [ Designated as safety issue: No ]

    Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:

    1. From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or
    2. From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence.
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Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
A Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Patient-initiated Famciclovir 1000 mg b.i.d. x 1 Day to Valacyclovir 500 mg b.i.d. x 3 Days in Immunocompetent Adults With Recurrent Genital Herpes

This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Genital Herpes
  • Drug: Famciclovir
    Famciclovir 500 mg tablet
    Other Name: Famvir
  • Drug: Valacyclovir
    Valacyclovir 500 mg capsule
    Other Name: Valtrex
  • Drug: Placebo matching famciclovir
    Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
  • Drug: Placebo matching valacyclovir
    Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
  • Experimental: Famciclovir
    Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
    Interventions:
    • Drug: Famciclovir
    • Drug: Placebo matching valacyclovir
  • Active Comparator: Valacyclovir
    Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
    Interventions:
    • Drug: Valacyclovir
    • Drug: Placebo matching famciclovir
Bodsworth N, Fife K, Koltun W, Tyring S, Abudalu M, Prichard M, Hamed K. Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. Curr Med Res Opin. 2009 Feb;25(2):483-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1179
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years old
  • History of at least 4 recurrences of genital herpes in the preceding 12 months
  • Lesions located on the external genitalia or anogenital region
  • Willing to discontinue suppressive treatment
  • Documented positive herpes simplex virus (HSV)
  • General good health, and history of normal renal function

Exclusion Criteria:

  • Women of childbearing potential not using approved form of contraceptive
  • Pregnant or nursing women
  • History of hypersensitivity to famciclovir, valacyclovir, or acyclovir
  • Known to be immunosuppressed
  • Known to have renal dysfunction
  • Receiving anti-herpes therapy
  • Known to have other genital tract disorders
  • Known to have condition which could interfere with drug absorption

Additional protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Germany
 
NCT00306787
CFAM810A2308
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP